Trial Outcomes & Findings for Comparison of Coagulation Factors During Laparoscopic Cholecystectomy (NCT NCT02568852)

NCT ID: NCT02568852

Last Updated: 2016-06-30

Results Overview

group1 and group 2(Duration of Operation)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: up to 2 hours
• Results posted on: 2016-06-30

Participant Flow

Participant milestones

Measure	Group 1 Laparoscopic cholecystectomy under general anaesthesia	Group 2 Laparoscopic cholecystectomy under combined anaesthesia (Spino epidural).
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Coagulation Factors During Laparoscopic Cholecystectomy

Baseline characteristics by cohort

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in under 10 mmHg pneumoperitoneum	Group 2 n=25 Participants Laparoscopic cholecystectomy in under 14 mmHg pneumoperitoneum	Total n=50 Participants Total of all reporting groups
Age, Continuous	46 years n=5 Participants	52 years n=7 Participants	48 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Turkey	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
ASA(American Society of Anesthesiologists ) scores	1 Scores on a scale(min:1 and max:6) n=5 Participants	2 Scores on a scale(min:1 and max:6) n=7 Participants	2 Scores on a scale(min:1 and max:6) n=5 Participants
BMI	28.1 kg/m^2 STANDARD_DEVIATION 4.0 • n=5 Participants	28.2 kg/m^2 STANDARD_DEVIATION 3.5 • n=7 Participants	28.15 kg/m^2 STANDARD_DEVIATION 3.72 • n=5 Participants

PRIMARY outcome

Timeframe: up to 2 hours

Population: All patients have gall bladder disease who are between 18-80 years old.

group1 and group 2(Duration of Operation)

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Duration of Operation	54 minutes Interval 45.0 to 80.0	65 minutes Interval 53.0 to 92.0

SECONDARY outcome

Timeframe: pre-operative

Population: All patients have gall bladder disease who are between 18-80 years old.

A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Fibrinogen Level	219 mg/dL Interval 138.0 to 318.0	261 mg/dL Interval 87.0 to 395.0

SECONDARY outcome

Timeframe: Post-operative 1 st hour

Population: All patients have gall bladder disease who are between 18-80 years old.

A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Fibrinogen Level	253 mg/dL Interval 214.0 to 382.0	320 mg/dL Interval 171.0 to 495.0

SECONDARY outcome

Timeframe: Post-operative 24th hour

Population: All patients have gall bladder disease who are between 18-80 years old.

A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Fibrinogen Level	352 mg/dL Interval 258.0 to 496.0	421 mg/dL Interval 250.0 to 760.0

SECONDARY outcome

Timeframe: pre-operative

Population: All patients have gall bladder disease who are between 18-80 years old.

measures of the extrinsic pathway of coagulation

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
PT(Prothrombin Time)	11.94 seconds Standard Deviation 0.64	11.78 seconds Standard Deviation 0.75

SECONDARY outcome

Timeframe: Post-operative 1st hour

measures of the extrinsic pathway of coagulation

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
PT(Prothrombin Time)	12.1 seconds Standard Deviation 0.53	12.69 seconds Standard Deviation 0.84

SECONDARY outcome

Timeframe: Post-operative 24th hours

Population: All patients have gall bladder disease who are between 18-80 years old.

measures of the extrinsic pathway of coagulation

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
PT(Prothrombin Time)	12.43 seconds Standard Deviation 0.86	13.63 seconds Standard Deviation 1.07

SECONDARY outcome

Timeframe: pre-operative

Population: All patients have gall bladder disease who are between 18-80 years old.

A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
D-Dimer	0.31 mg/L Standard Deviation 0.08	0.34 mg/L Standard Deviation 0.10

SECONDARY outcome

Timeframe: Post-operative 1st hour

Population: All patients have gall bladder disease who are between 18-80 years old.

A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
D-Dimer	0.56 mg/L Standard Deviation 0.22	1.06 mg/L Standard Deviation 0.7

SECONDARY outcome

Timeframe: Post-operative 24th hours

Population: All patients have gall bladder disease who are between 18-80 years old.

A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
D-Dimer	0.91 mg/L Standard Deviation 0.34	1.61 mg/L Standard Deviation 0.95

SECONDARY outcome

Timeframe: pre-operative

Population: All patients have gall bladder disease who are between 18-80 years old.

measures of the intrinsic pathway of coagulation

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
aPTT(Activated Partial Thromboplastin Time)	22.80 seconds Standard Deviation 1.48	25.0 seconds Standard Deviation 2.86

SECONDARY outcome

Timeframe: Post-operative 1st hour

Population: All patients have gall bladder disease who are between 18-80 years old.

measures of the intrinsic pathway of coagulation

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
aPTT(Activated Partial Thromboplastin Time)	23.42 seconds Standard Deviation 1.54	25.25 seconds Standard Deviation 2.35

SECONDARY outcome

Timeframe: Post-operative 24th hours

Population: All patients have gall bladder disease who are between 18-80 years old.

measures of the intrinsic pathway of coagulation

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
aPTT(Activated Partial Thromboplastin Time)	24.54 seconds Standard Deviation 2.16	26.92 seconds Standard Deviation 2.92

SECONDARY outcome

Timeframe: pre-operative

Population: All patients have gall bladder disease who are between 18-80 years old.

measures of the extrinsic and intrinsic pathway of coagulation

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Thrombin Time(TT)	19.88 seconds Standard Deviation 1.58	20.57 seconds Standard Deviation 2.12

SECONDARY outcome

Timeframe: Post-operative 1st hour

Population: All patients have gall bladder disease who are between 18-80 years old.

measures of the extrinsic and intrinsic pathway of coagulation

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Thrombin Time(TT)	17.78 seconds Standard Deviation 0.74	17.61 seconds Standard Deviation 1.02

SECONDARY outcome

Timeframe: Post-operative 24th hours

Population: All patients have gall bladder disease who are between 18-80 years old.

measures of the extrinsic and intrinsic pathway of coagulation

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in general anaesthesia Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia	Group 2 n=25 Participants Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural). General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia
Thrombin Time(TT)	16.06 seconds Standard Deviation 1.05	16.01 seconds Standard Deviation 0.72

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group 1 n=25 participants at risk Laparoscopic cholecystectomy in under general anaesthesia.(10 mmHg CO2 pneumoperitoneum)	Group 2 n=25 participants at risk Laparoscopic cholecystectomy in under spinal epidural anaesthesia.(10 mmHg CO2 pneumoperitoneum)
Cardiac disorders Hypotension	4.0% 1/25 • Number of events 1 • up to 24 weeks In this time period, hypotension,urinary retention,nausea and headache were observed.	8.0% 2/25 • Number of events 2 • up to 24 weeks In this time period, hypotension,urinary retention,nausea and headache were observed.
Renal and urinary disorders urinary retension	0.00% 0/25 • up to 24 weeks In this time period, hypotension,urinary retention,nausea and headache were observed.	4.0% 1/25 • Number of events 1 • up to 24 weeks In this time period, hypotension,urinary retention,nausea and headache were observed.
Gastrointestinal disorders Nausea/vomiting	16.0% 4/25 • Number of events 4 • up to 24 weeks In this time period, hypotension,urinary retention,nausea and headache were observed.	4.0% 1/25 • Number of events 1 • up to 24 weeks In this time period, hypotension,urinary retention,nausea and headache were observed.
Nervous system disorders headache	0.00% 0/25 • up to 24 weeks In this time period, hypotension,urinary retention,nausea and headache were observed.	4.0% 1/25 • Number of events 1 • up to 24 weeks In this time period, hypotension,urinary retention,nausea and headache were observed.

Additional Information

Dr.Turgut Donmez

Haseki-156

Phone: 00905347400967

Email: surgeont73@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place